| CTRI Number |
CTRI/2026/02/104131 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Ways to Control Gag Reflex in Children During upper Dental Impressions |
|
Scientific Title of Study
|
Effect of Local Anaesthesia and Temporal Tap technique on gag reflex during maxillary arch impression in children: A Cross-over Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Bargale |
| Designation |
Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9586115657 |
| Fax |
|
| Email |
drseemabargale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Bargale |
| Designation |
Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9586115657 |
| Fax |
|
| Email |
drseemabargale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shinde |
| Designation |
PG Student |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9130670670 |
| Fax |
|
| Email |
divyashinde6@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M. Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia, Vadodara, Gujarat (PIN-391760) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema Bargale |
Department of Pediatric and Preventive Dentistry |
Depatment No.3, First Floor, Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara
Vadodara
GUJARAT |
9586115657
drseemabargale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gag reflex during impression making in children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local Anesthesia |
1.8ml Local Anesthesia solution (2% lignocaine with 1:10000 adrenaline) will be incorporated in the impression material (alginate) along with water while mixing to reduce the gag reflex in children while recording impression. |
| Intervention |
Temporal Tap Technique |
Temporal tapping will be performed by tapping along the temporal sphenoidal diagnostic line along with verbal commands like you will find it easy, you can do it, there is no reason to worry, etc. The Tapping will be done on both sides. The Statements to the left side should be positive and rational. Those to the right should be negative, emotional, and authoritative, The suggestive statements should be simple, direct commands. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
2.Children first dental visit
3.Children with Frankl score 3 or 4 in the rating scale
4.Children with GSI score greater than or equal to grade II
5.Children with no history of dental impressions previously made |
|
| ExclusionCriteria |
| Details |
1. Children with systemic illness.
2. Children with medically and developmentally compromising conditions.
3. Children whose parents did not gave written consent.
4. Children allergic to Local Anaesthesia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the more effective non-pharmacological approach for managing gag reflex in pediatric dental patients during dental impression procedures. |
There is no Follow-up. Baseline GPI (Gag Prevention Index) score is taken. There will be 10 minutes washout period between the two interventions. After each intervention GSI (Gag Severity Index) score is recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effect of Local Anesthesia and Temporal Tap Technique on Gag Reflex During Maxillary Arch Impression in Children: A Randomized Cross-Over Study
This randomized cross-over study will be conducted to compare the effectiveness of local anesthesia and the temporal tap technique in controlling the gag reflex during maxillary arch impression procedures in children aged 6–12 years. Forty-four children exhibiting a gag reflex of grade II or above based on Gag severity Index (GSI) will be included. Each participant will receive both interventions in a randomized sequence, separated by a 10-minute washout period. The gag reflex response will be measured using the Gag Prevention Index, while dental anxiety will be assessed using the Buchanan Facial Image Scale. The findings of this study will help determine the more effective non-pharmacological approach for managing gag reflex in pediatric dental patients, thereby improving patient comfort and cooperation during dental impression procedures. |